Effects of Physical Training on Bone Turnover and Quality of Life in Osteopenic Postmenopausal Women.

N/ACompletedNCT03195517

University Of Perugia33 enrolled

Overview

The aim of our research was to define both in vivo and in vitro whether and to what extent an high-impact exercise program would affect bone cell turnover and improve the QoL in osteopenic postmenopausal women.

Subjects were selected among those attending the "Bone and Mineral Metabolism Disorders" Clinic of Perugia University, Italy, since May 2nd 2015 and January 31st 2016. A total of 33 post-menopausal women volunteered to participate in the study.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteopenia Bone Turnover Markers Quality of Life

Interventions

Physical exerciseOTHER

Eligibility

Sex: FEMALEMin age: 52 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * postmenopausal * bone mineral density T-score less than -1 but more than -2.5 in the total hip or lumbar spine (L1-L4) by dual energy x-ray absorptiometry * be able to attend an exercise program 2 times per week over the 3-month period * stated availability throughout the entire study period Exclusion Criteria: * secondary causes of bone loss such as osteomalacia, glucocorticoid medication * co-morbidities that would interfere with participation in exercise such as severe heart or pulmonary disease, inflammatory joint disease, severe osteoarthritis, psychiatric condition * physical or orthopaedic disabilities that would place the subject at risk or limit their ability to perform exercise * a past vertebral fracture * history of chronic diseases, such as renal, hepatic, cardiac, and rheumatic diseases * current or prior use of drugs that could interfere with bone mass (i.e. glucocorticoids, antiresorptive drugs and hormonal replacement therapy)

Outcomes

Primary Outcomes

Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP)

P1NP is the most reliable serum marker of bone formation commercially available at the moment

Time frame: Baseline - Week 4

Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP).

P1NP is the most reliable serum marker of bone formation, commercially available at the moment.

Time frame: Week 4 - Week 12

Serum Sclerotin Levels

Sclerostin has been proposed as the check-point where physical activity (PA) acts to modulate bone metabolism.

Time frame: Baseline - W4

Sclerostin

Sclerostin has been proposed as the check-point where PA acts to modulate bone metabolism.

Time frame: Week 4 - Week 12

Variation in Serum Carboxy-terminal Telopeptide of Collagen Type I (sCTX)

Serum carboxy-terminal telopeptide of collagen type I (sCTX) is one of the most sensitive and specific bone resorption markers of osteoclast-mediated collagen degradation

Time frame: Baseline - Week 4

Variation of Serum Carboxy Terminal Telopeptide of Collagen Type I (sCTX)

Serum carboxy terminal telopeptide of collagen type I (sCTX) is one of the most sensitive and specific bone resorption markers of osteoclast-mediated collagen degradation.

Time frame: Week 4 - Week 12

Variation in Circulating Osteoprogenitor Cells (OPCs)

Measurements of circulating OPCs with stem cell characteristics (CD34+) and express bone-specific proteins such as alkaline phosphatase (AP +) and osteocalcin (OCN +).

Time frame: Baseline - Week 4

Data from ClinicalTrials.gov

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Secondary Outcomes

Variation in Health-related Quality of Life (QoL)

Health-related Quality of Life evaluated using the Quality of Life questionnaire of the European Foundation for Osteoporosis (QUALEFFO). The score ranges from 0, corresponding to the best QoL, to 100, corresponding to the worst QoL. Total score is the average value of 5 sub scores, corresponding to pain, physical function, mental function, social function and general health perception.

Time frame: Baseline - Week 4

Variation in Health-related Quality of Life (QoL).

Time frame: Week 4 - Week 12